Many have asked recently for an update about the treatment to target IL-15 to induce durable responses in patients with vitiligo. There was a lot of excitement around this approach when we published our paper about a year and a half ago in the summer of 2018 (read about it here), especially from me! The idea was that autoimmune memory cells form within vitiligo spots and are responsible for the return of disease at those exact same spots when treatments are stopped. We discovered that those cells need IL-15 to stay in the skin, and therefore blocking IL-15 removes them, reversing vitiligo, and avoiding relapse of disease when the treatment is stopped. This was all shown in mice, not humans yet. But we did study human skin and found the same cells and same pathways active, so we have good reason to believe that this will work for human patients as well.
Based on these exciting results, I applied for a grant from the Immune Tolerance Network (ITN), a group funded by the National Institutes of Health (NIH) to support human clinical trials to test drugs that could have long-lasting benefit for patients with autoimmune diseases. They thought this was a great idea as well and funded the grant application to prepare for a clinical trial in vitiligo patients. In this trial, we proposed to test an existing antibody that targets the cytokine IL-15. Of course, I helped prepare for the trial, which required getting approval from the FDA to conduct the trial, obtaining the drug, and writing the protocol (or plan) for the trial to follow.
During this process, I obtained support from Medicxi Ventures, a venture capital firm located in London and Geneva, to start my own company to create a drug to target this pathway for vitiligo as well. This is all great news, because it seems that many people (very smart and discerning people) agree that this could be a game-changing new treatment for vitiligo patients. As founder of this new company called Villaris Therapeutics, I have financial ties to the company, and therefore a potential “conflict of interest” or COI with the proposed trial sponsored by the ITN. This means that if I could benefit personally from the success of the trial, there would be undue pressure on me when recruiting subjects, collecting data, etc.
Appropriately, everyone agreed that I could no longer lead the trial for the ITN because of my potential COI with Villaris Therapeutics, and thus the ITN elected a new “protocol chair” and principle investigator to lead the trial. This created a delay, and so the trial did not begin when it was projected, sometime in 2019. It is still planned to start soon, possibly in the spring of 2020, but unexpected delays can always occur, particularly because everyone is making sure the study is done safely and correctly. This is not a fast process and requires lots of patience. But it is still moving forward, and everyone is just as excited for the trial as we were over a year ago.
Now, we at Villaris believe that we are developing an even better drug than anything that’s currently available, and we are putting all of our effort into this. It’s no secret that our drug will target the IL-15 receptor rather than the cytokine, and for many reasons we think this will be a better strategy, more effective and thus longer-lasting, as well as safer. This is important and worth doing right, so we’re taking the time necessary to design this new treatment in a way that will benefit vitiligo patients the most. We actually don’t think it will take very long and hope to be testing it in early human trials within the next 2 years. Things are moving quickly because we’re passionate about this and it is our only goal. I’m working with the best of the best at Villaris – they’re brilliant, passionate, caring, and the personality types to “get it done”. Read more about the team and our approach at the company website at https://villaristherapeutics.com
So, don’t be discouraged that this drug isn’t ready yet, things are still moving full steam ahead and everyone just wants to be sure it’s safe, effective, and the best it can be. I’ll update everyone on progress when I can, but please know that I’m putting the same passion into this that I do everything else, including the clinic, our research, and advocacy work. Thank you for your support!
